[Federal Register Volume 81, Number 105 (Wednesday, June 1, 2016)]
[Rules and Regulations]
[Pages 34908-34909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12853]



[[Page 34908]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 412 and 495

[CMS-3310 & 3311-F3]
RINs 0938-AS26 and AS58


Medicare and Medicaid Programs; Electronic Health Record 
Incentive Program--Stage 3 and Modifications to Meaningful Use in 2015 
Through 2017; Corrections and Correcting Amendment

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule; corrections and correcting amendment.

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SUMMARY: This document corrects certain technical and typographical 
errors that appeared in the October 16, 2015 final rule with comment 
period titled ``Medicare and Medicaid Programs; Electronic Health 
Record Incentive Program--Stage 3 and Modifications to Meaningful Use 
in 2015 through 2017.''

DATES: This document is effective on June 1, 2016.

FOR FURTHER INFORMATION CONTACT: Elizabeth S. Holland (410) 786-1309.

SUPPLEMENTARY INFORMATION: 

I. Background

    In FR Doc. 2015-25595 of October 16, 2015 (80 FR 62762), in the 
final rule with comment period titled ``Medicare and Medicaid Programs; 
Electronic Health Record Incentive Program--Stage 3 and Modifications 
to Meaningful Use in 2015 through 2017'' (hereafter referred to as the 
2015 EHR Incentive Programs final rule with comment period) there were 
a number of technical errors that were identified and corrected in FR 
Doc. 2016-04785 of March 4, 2016 (81 FR 11447), titled ``Medicare and 
Medicaid Programs; Electronic Health Record Incentive Program--Stage 3 
and Modifications to Meaningful Use in 2015 Through 2017; Corrections 
and Correcting Amendment'' .\1\ This document corrects additional 
technical and typographical errors that appeared in the 2015 EHR 
Incentive Programs final rule with comment period. The provisions in 
this correcting amendment are treated as if they had been included in 
the 2015 EHR Incentive Programs final rule with comment period.
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    \1\ We note that the name of the program was stated incorrectly 
in the title of the March 4, 2016 Corrections and Correcting 
Amendment (81 FR 11447).
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II. Summary of Errors

A. Summary of Errors in the Preamble

    We specified in the October 16, 2015 final rule (80 FR 62903-62905) 
that the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) 
(Pub. L. 114-10) amended section 1848(a)(7)(A) of the Social Security 
Act (the Act) to sunset the meaningful use payment adjustment for 
eligible professionals (EPs) at the end of calendar year (CY) 2018 and 
added section 1848(q) of the Act requiring the establishment of a 
Merit-based Incentive Payment System (MIPS), which would incorporate 
certain existing provisions and processes related to meaningful use. 
However, on the following pages, we made erroneous statements 
concerning a meaningful use payment adjustment for EPs under section 
1848(a)(7)(A) of the Act in 2019:
     Page 62905, in our response to a public comment on the EHR 
reporting period for a payment adjustment year for EPs, we erroneously 
added a phrase stating that the 90-day EHR reporting period in 2017 for 
Stage 3 would also apply for the purposes of avoiding the payment 
adjustment in 2019.
     Page 62906, in TABLE 18--EHR REPORTING PERIODS AND RELATED 
PAYMENT ADJUSTMENT YEARS FOR EPs, we incorrectly stated that, in 2017, 
the EHR reporting period for a payment adjustment year for Medicaid EP 
returning participants demonstrating Stage 3 is any continuous 90-day 
period in CY 2017 and applies to avoid a payment adjustment in CY 2019 
if they successfully attest by February 28, 2018.
    On page 62920, in TABLE 21--BURDEN ESTIMATES STAGE 3, we 
inadvertently included text that was proposed but not finalized which 
stated that, the EP, eligible hospital or CAH incorporates into the 
patient's record an electronic summary of care document ``from a source 
other than the provider's EHR system''. We are correcting this 
technical error to ensure that the language in the table is consistent 
with the language in the preamble and regulations text.

B. Summary of Errors in the Regulations Text

    On page 62942, in paragraph (1)(ii)(C)(2) of the definition of 
``EHR reporting period for a payment adjustment year'' at Sec.  495.4, 
we incorrectly established an EHR reporting period in CY 2017 for a 
payment adjustment year identified as the ``FY 2019 payment adjustment 
year.'' As noted previously, the MACRA amended section 1848(a)(7)(A) of 
the Act to sunset the meaningful use payment adjustment for EPs at the 
end of CY 2018. Therefore, we are amending the definition of ``EHR 
reporting period for a payment adjustment year'' by removing and 
reserving paragraph (1)(ii)(C)(2) to correct this error.
    On page 62952, in Sec.  495.24(d)(7)(ii)(B)(2) (Stage 3 meaningful 
use objectives and measures for EPs, eligible hospitals, and CAHs for 
2018 and subsequent years); we inadvertently included language for the 
eligible hospital or CAH measure that we did not include in the EP 
measure. We are correcting this technical error by revising the 
language to ensure that the regulations text for the eligible hospital 
or CAH measure is consistent with the regulations text for the EP 
measure.

III. Waiver of Proposed Rulemaking, 60-Day Comment Period, and Delay in 
Effective Date

    Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), 
the agency is required to publish a notice of the proposed rule in the 
Federal Register before the provisions of a rule take effect. 
Similarly, section 1871(b)(1) of the Act requires the Secretary to 
provide for notice of the proposed rule in the Federal Register and 
provide a period of not less than 60 days for public comment. In 
addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of 
the Act mandate a 30-day delay in effective date after issuance or 
publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA 
provide for exceptions from the notice and comment and delay in 
effective date APA requirements; in cases in which these exceptions 
apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide 
exceptions from the notice and 60-day comment period and delay in 
effective date requirements of the Act as well. Section 553(b)(B) of 
the APA and section 1871(b)(2)(C) of the Act authorize an agency to 
dispense with normal rulemaking requirements for good cause if the 
agency makes a finding that the notice and comment process are 
impracticable, unnecessary, or contrary to the public interest. In 
addition, both section 553(d)(3) of the APA and section 
1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay 
in effective date where such delay is contrary to the public interest 
and an agency includes a statement of support.
    We believe that this correcting amendment does not constitute a 
rulemaking that would be subject to these requirements. This correcting

[[Page 34909]]

amendment corrects technical and typographic errors in the preamble and 
regulation text included in the 2015 EHR Incentive Programs final rule 
with comment period. The corrections contained in this document are 
consistent with, and do not make substantive changes to, the policies 
that were adopted subject to notice and comment procedures in the final 
rule with comment period. As a result, the corrections made through 
this correcting amendment are intended to ensure that the 2015 EHR 
Incentive Programs final rule with comment period accurately reflects 
the policies adopted in that rule. In addition, even if this were a 
rulemaking to which the notice and comment procedures and delayed 
effective date requirements applied, we find that there is good cause 
to waive such requirements. Undertaking further notice and comment 
procedures to incorporate the corrections in this document into the 
final rule with comment period or delaying the effective date would be 
contrary to the public interest because it is in the public's interest 
for EPs, eligible hospitals, and critical access hospitals to be 
advised, in a timely manner, of the meaningful use criteria and EHR 
reporting periods that they must meet in order to qualify for Medicare 
and Medicaid electronic health record incentive payments and avoid 
payment reductions under Medicare, and to ensure that the final rule 
with comment period accurately reflects our policies as of the date 
they take effect and are applicable. Furthermore, such procedures would 
be unnecessary due to the changes in the law made by the MACRA, under 
which the meaningful use payment adjustment for EPs under section 
1848(a)(7)(A) of the Act will sunset at the end of CY 2018. The 
statements identified above in the preamble and the regulations text 
concerning a payment adjustment in 2019 are moot as a result of those 
changes in the law. In addition, such procedures would be unnecessary, 
as we are not altering our policies; rather, we are simply implementing 
correctly the policies that we previously proposed, received comment 
on, and subsequently finalized. This correcting document is intended 
solely to ensure that the 2015 EHR Incentive Programs final rule with 
comment period accurately reflects these policies. Therefore, we 
believe we have good cause to waive the notice and comment and 
effective date requirements.

IV. Correction of Errors

    In FR Doc. 2015-25595 of October 16, 2015 (80 FR 62762), we are 
making the following corrections:
    1. On page 62905, first column, first partial paragraph, lines 7 
through 10, the phrase ``the payment adjustment in 2019 for returning 
participants and for the payment adjustment in 2018 for new 
participants'' is corrected to read ``the payment adjustment in 2018 
for new participants''.
    2. On page 62906, in TABLE 18--EHR REPORTING PERIODS AND RELATED 
PAYMENT ADJUSTMENT YEARS FOR EPs, the entry for 2017 is corrected to 
read as follows:

----------------------------------------------------------------------------------------------------------------
                                                      2017
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                                     EHR reporting period   Applies to avoid a
                                        for a payment       payment  adjustment     Applies to avoid a payment
                                       adjustment year          in CY 2018            adjustment in CY 2019
----------------------------------------------------------------------------------------------------------------
EP new participants (including      Any continuous         Yes, if EP            N/A.
 those demonstrating Stage 3 under   90[dash]day period     successfully
 Medicare or Medicaid).              in CY 2017.            attests by October
                                                            1, 2017.
EP returning participants.........  N/A..................  N/A.................  N/A.
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    3. On page 62920, TABLE 21 --BURDEN ESTIMATES STAGE 3, third 
column, third full paragraph (Measure 2), lines 8 and 10, the phrase 
``an electronic summary of care document from a source other than the 
provider's EHR system.'' is corrected to read ``an electronic summary 
of care document.''.

List of Subjects in 42 CFR Part 495

    Administrative practice and procedure, Electronic health records, 
Health facilities, Health professions, Health maintenance organizations 
(HMO), Medicaid, Medicare, Penalties, Privacy, Reporting and 
recordkeeping requirements.

    As noted in section II.B. of this correcting amendment, the Centers 
for Medicare & Medicaid Services is making the following correcting 
amendments to 42 CFR part 495:

PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY 
INCENTIVE PROGRAM

0
1. The authority citation for part 495 continues to read as follows:

    Authority:  Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec.  495.4  [Amended]

0
2. In Sec.  495.4, paragraph (1)(ii)(C)(2) of the definition of ``EHR 
reporting period for a payment adjustment year'' is removed and 
reserved.


Sec.  495.24  [Amended]

0
3. In Sec.  495.24, paragraph (d)(7)(ii)(B)(2) is amended by removing 
the phrase ``an electronic summary of care document from a source other 
than the provider's EHR system.'' and adding in its place the phrase 
``an electronic summary of care document.''.

    Dated: May 25, 2016.
Madhura Valverde,
Executive Secretary to the Department, Department of Health and Human 
Services.
[FR Doc. 2016-12853 Filed 5-31-16; 8:45 am]
 BILLING CODE 4120-01-P